Overview

This document applies to the basic safety and essential performance requirements for infant incubators. These particular requirements specify safety requirements for infant incubators RS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the manufacturer has demonstrated in his risk management file that the risk presented by the hazard has been found to be of an acceptable level when weighed against the benefit of treatment from the device. These particular requirements do not apply to: - infant transport incubators (see IEC 60601-2-20 for information); - infant heaters (see IEC 60601-2-21 for information); - devices for supplying heat through blankets, mats, and mattresses in medical applications (for information, see IEC 80601-2-35); - infant phototherapy devices (for information, see IEC 60601-2-50). The standard differs from DIN EN IEC 60601-2-19 (VDE 0750-2-19):2022-08 as follows: a) some terms and definitions have been revised; b) the list and information on measuring the field strength of the low-frequency electromagnetic field of the infant incubator have been supplemented in the Clause "Operating instructions"; c) the sound pressure level value has been adjusted in the Clause "Sound level within the patient compartment"; d) the text section regarding the minimum and maximum sound level values has been revised in the Clause "Sound level of the audible alarm". In addition, reference standards have been added. e) an addition regarding biocompatibility has been made; f) the Clause "Accuracy of the incubator temperature display" has been revised with regard to measurement deviations; g) a section of text in the Subclause "Application" has been deleted and the maximum incubator temperature has been adjusted; h) the Clause "Electromagnetic disturbances - Requirements and tests" has been adjusted; i) Annex AA has been revised, updated, and adjusted; j) The bibliography has been supplemented and revised.

Document: references other documents

Responsible national committee

DKE/UK 804.10 - Medizinische Geräte in der Pädiatrie